Cook G26945Recalls & reported problems
Cook Incorporated · Central Venous Tray Triple Lumen Polyurethane Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002269453), received between Nov 9, 2017 and Nov 7, 2018 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Crack” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Crack2
- Partial Blockage1
Patient problems
- No Code Available2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2018Crack; Crack
IT WAS REPORTED THE BLUE HUB ON A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER WAS FOUND TO BE CRACKED CAUSING LEAKAGE. THE DEVICE WAS PLACED IN THE RIGHT FEMORAL VEIN ON (B)(6) 2018 AND FOUND CRACKED ON (B)(6) 2018 A FEW HOURS AFTER THE SMARTSITE NEEDLE FREE VALVE WAS CHANGED. THE PATIENT WAS RECEIVING CONTINUOUS AND SINGLE MEDICATION INFUSIONS. THE DEVICE WAS REMOVED AND REPLACED WITH A LIKE DEVICE. MEDWATCH MW5080167 WAS RECEIVED ON 26OCT2018 DOCUMENTING THIS EVENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 8045605 ↗InjuryAug 1, 2018Crack; Crack
MalfunctionNov 9, 2017Partial Blockage; Partial Blockage
ADDITIONAL INFORMATION: PEDIATRIC PHYSICIAN WAS PLACING A RIGHT TRIPLE LUMEN INTRAJUGULAR (IJ) LINE. THIS MDR IS BEING REPORTED BASED ON INVESTIGATION OF THE WIRE GUIDE, IT WAS DISCOVERED THE DISTAL WELD CONNECTION LOCATED AT THE ¿J¿ TIP END WAS BROKEN, RESULTING IN COIL ELONGATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7014711 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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